FDA 510(k) Obstetrics & Gynecology Devices
FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview
FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.
Key categories:
- Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
- Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
- Breast pumps and lactation aids - electric and manual breast pumps
- Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
- Pregnancy test systems - hCG detection devices for professional and home use
4499
Total
4485
Cleared
168d
Avg (2y)
1976
Since
1727 Obstetrics & Gynecology devices
Cleared
Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
69d
Cleared
Nov 07, 2008
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
HFE
Brush, Endometrial
108d
Cleared
Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
HGM
System, Monitoring, Perinatal
81d
Cleared
Sep 30, 2008
AVAULTA SUPPORT SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
25d
Cleared
Sep 26, 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
HET
Laparoscope, Gynecologic (and Accessories)
176d
Cleared
Sep 17, 2008
G-MOPS G5 SERIES
MQL
Media, Reproductive
152d
Cleared
Sep 16, 2008
G-1 V5
MQL
Media, Reproductive
151d
Cleared
Sep 16, 2008
G-2 V5
MQL
Media, Reproductive
151d
Cleared
Sep 02, 2008
G-IVF G5 SERIES
MQL
Media, Reproductive
137d
Cleared
Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
130d
Cleared
May 28, 2008
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
HGM
System, Monitoring, Perinatal
30d
Cleared
May 15, 2008
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
346d
Cleared
May 02, 2008
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
GEI
Electrosurgical, Cutting & Coagulation & Accessories
109d
Cleared
Apr 10, 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
76d
Cleared
Feb 12, 2008
SINGLE STEP MEDIUM
MQL
Media, Reproductive
148d
Cleared
Feb 08, 2008
MEDLINE DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
114d
Cleared
Jan 30, 2008
LYOPHILIZED MULTIBLAST MEDIUM KIT
MQL
Media, Reproductive
135d
Cleared
Jan 25, 2008
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
MQL
Media, Reproductive
130d
Cleared
Jan 23, 2008
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
HDW
Diaphragm, Contraceptive (and Accessories)
456d
Cleared
Dec 20, 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
HGM
System, Monitoring, Perinatal
56d
Cleared
Dec 19, 2007
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
62d
Cleared
Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
115d
Cleared
Oct 09, 2007
PROBE HOLDER SYSTEM
LKF
Cannula, Manipulator/injector, Uterine
141d
Cleared
Oct 05, 2007
VCARE RETRACTOR/ELEVATOR
LKF
Cannula, Manipulator/injector, Uterine
87d
Cleared
May 23, 2007
SALINE/ CONTRAST MEDIA INFUSION CATHETER
LKF
Cannula, Manipulator/injector, Uterine
171d
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